Liquid catheter, particularly a urinary catheter, method and delivery device

ABSTRACT

A liquid catheter, in particular a urinary catheter, includes a catheter shaft part ( 21 ) with a longitudinal liquid channel extending between a proximal and distal side thereof, and an anchoring body ( 22 ). The catheter body is intended to be received fully internally in a body cavity, such as in particular the urine bladder ( 50 ), and to drain the bladder from inside via the urethra ( 51 ). The catheter body has a length to span a distance between the bladder and a closure point ( 35 ) of the sphincter urethra. An operating member ( 24,25 ) is connected durably to the catheter body to enable a user to carry the catheter body transluminally out of the bladder past the closure point. An insertion device for the catheter includes an insertion sleeve which can be carried transluminally as far as the urine bladder and from which the catheter body can be carried into the bladder.

The present invention relates to a liquid catheter, in particular aurinary catheter, comprising a catheter body which comprises a shaftpart with a longitudinal liquid channel is intended and adapted to allowa liquid flow between a distal side and a proximal side thereof, and ananchoring body on the distal side of the shaft part which is able andadapted to take on a relatively slender state in order to be receivedtransluminally in this state in a body cavity of a patient, inparticular a urine bladder, and to take on a transversely expanded statein order to prevent an unintended escape of the catheter body from thebody cavity. The invention also relates to an insertion device and to amethod for self-catheterization of a urine bladder with a catheter,wherein the catheter comprises a catheter body which is provided with atleast one longitudinal liquid channel for guiding a liquid flow from adistal outer end to a proximal outer end thereof, and wherein thecatheter body is at least partially introduced transurethrally into theurine bladder.

It is otherwise noted that within the scope of the present invention theterms “proximal”, “distal” and conjugations thereof indicate positionswhich are related to an external environment of the user of thecatheter. A proximal outer end is thus the outer end which is directedtoward the user at first use and will be handled by him/her, while thedistal side refers to the opposite side, in this case remote from theuser, with which the catheter is inserted transluminally into the bodyof the user.

Urinary catheters are mainly applied for the purpose of catheterizingthe bladder, wherein the bladder of a patient is drained by means of thecatheter. Such a catheterization is important in patients who arebedridden or otherwise insufficiently able to go to the toilet normally,but also provides a solution for people who go without a toilet incertain circumstances, such as pilots and race drivers. In addition,urinary catheters provide a solution for users coping with a bladderdeficiency in the sense that the urine bladder is not autonomously ableto build up sufficient pressure to overcome the closing force of thesphincter urethra.

There are different types, shapes and sizes of urinary catheters. Animportant distinction is made here between so-called intermittentcatheters and indwelling catheters. The first type is inserted beforeeach urination and removed again afterward, while the latter type isintended to be worn by a user for a longer period for repeated use.

An intermittent catheter is generally not much more than a hollow tubewhich is introduced transurethrally with a distal tip into the urinebladder for effective drainage thereof via the open connection thuscreated through the sphincter urethra. A drawback of this type ofcatheter is that the insertion thereof requires a certain degree ofdexterity and is in any case an unpleasant and frequently painfulexperience which has to be repeated for each urination. All in all, aurination cycle hereby becomes a relatively time-consuming andunpleasant activity for the user, and is not exactly free of medicalrisk. Furthermore, such a catheter does not provide a solution for thestated users suffering from a bladder deficiency, particularly when theyare travelling for longer period of time.

These drawbacks are partially obviated by an indwelling catheter sincethis requires less frequent replacement and is suitable for successiveurinations. A known, if not the best known embodiment of such a urinarycatheter is the so-called Foley catheter. An example of this type ofurinary catheter is described in international patent applicationPCT/SE82/00124. This catheter comprises a shaft part in the form of along thin tube with a somewhat rounded tip to allow easier insertion.Situated immediately below the tip is an inlet opening, followed by ananchoring body in the form of an inflatable balloon which surrounds theshaft part. After being inserted into the urine bladder via the urethra,sterile water or other suitable liquid is guided into the balloon via aninflation channel provided for this purpose in the shaft part in orderto inflate the balloon. The balloon thus anchors the catheter in thebladder in order to prevent unintended escape thereof, while the shaftpart protrudes through the sphincter urethra to provide an openconnection from the urine bladder to the outside via the inlet openingso that the bladder can be fully drained via a liquid channel providedfor this purpose in the catheter shaft part.

Because such a catheter can drain liquid continuously, a proximal outletthereof usually debouches in a collecting container, such as forinstance a urine bag, which is worn on the body or in the clothing. Ifdesired, a hydrophilic material can be applied in the collectingcontainer to absorb the urine irreversibly, in combination withbactericide and deodorizing agents. After a determined indwelling timeconsidered as safe, the liquid is evacuated from the balloon, afterwhich the catheter can be removed and, if desired, exchanged.

Because such a catheter need not be inserted and removed for eachurination, from this point of view it provides the user with aconsiderably higher degree of comfort. The insertion of such a catheteris usually more complex than of an intermittent catheter, and thereforerequires the necessary skill. Furthermore, the insertion of anindwelling catheter generally involves a danger of infections occurring,so that the procedure must preferably be carried out in a sterileenvironment which, certainly outside a hospital, can seldom beguaranteed. The introduction of a Foley catheter is therefore deemed asan operation reserved for only a doctor or nurse. However, due to thedurable operation of an indwelling catheter the user does not have torely constantly on assistance from a doctor or nurse, whereby this typeof catheter is therefore very popular in cases suitable for this type ofcatheter.

In contrast however, the constant presence of the catheter may causeirritations. Because of the durable nature of this type of cathetergreater demands are therefore made of the profile, i.e. the outerdiameter, thereof so as to prevent the urethra being stretched too muchthereby, which could otherwise result in discomfort or even in seriouscomplications. There is moreover a continuous, relatively opencommunication between the urine bladder and the external collectingcontainer, and this forms a danger, not to be underestimated, of thedevelopment of bladder infection, infections of the urethra of evenkidney disorders.

In order to obviate these drawbacks the U.S. Pat. No. 6,855,126describes an indwelling catheter comprising a shaft part with a magneticvalve therein and a specially formed anchoring body thereon. After beinginserted the anchoring body can be manipulated from a compact firststate to an expanded second state using a transluminal operating memberespecially adapted for the purpose and an elaborate system of screwthreads. The operating member can then be removed in order to leaveclear the whole shaft diameter for the purpose of the intended drainingoperation. For the same drainage capacity a shaft profile can thussuffice which is significantly smaller than in the case of a classicindwelling catheter in which an inflation channel is also provided.Finally, the magnetic valve avoids a constant open connection between aproximal outlet of the catheter, which protrudes externally for instanceinto a collecting container, and the internal distal side of thecatheter, so as to prevent the introduction of contamination, bacteriaand other micro-organisms. The valve opens automatically under theinfluence of urine pressure prevailing in the bladder and urine flowfrom the bladder, and closes itself when this flow ceases, i.e. when thebladder has been sufficiently emptied.

Although this catheter known from U.S. Pat. No. 6,855,126 herebyobviates a number of drawbacks of the classic Foley indwelling catheter,it still has the drawback that the constant presence of the shaft partin the urethra, although this is much thinner than in the classicindwelling catheter, can still cause irritations and infections. Theautonomous drainage of this catheter also requires a proximal outlet todebouch in a collecting container, which must therefore be wornconstantly and exchanged in good time.

The present invention has for its object, among others, to provide aliquid catheter, in particular a urinary catheter, an insertion deviceand a method which also obviate these drawbacks to at least significantextent.

In order to achieve the intended object a liquid catheter, in particulara urinary catheter, of the type stated in the preamble has the featureaccording to the invention that, proximally of the anchoring body, thecatheter body has on the one hand a sufficient length to span a distancebetween the body cavity and a closure point of a luminal sphincter, thaton the other hand the catheter body is able and adapted to be fullyreceived in the body cavity, distally of the closure point, and that atleast one operating member is connected durably to the catheter body,which operating member extends proximally from the catheter body and isintended and adapted to enable a user to early the catheter bodytransluminally out of the body cavity past the closure point with atleast the proximal side of the shaft part.

A maximum urethral closing pressure of the sphincter urethra prevails atthe position of said closure point. With the operating member proximallyaccessible to the user the catheter can be taken transluminally out ofthe body cavity past this closure point with at least the proximal outerend of the shaft part in order to overcome this pressure, wherein thelongitudinal liquid channel in the catheter shaft part forms an openconnection along which urine can leave the body cavity. As soon as thebody cavity has thus been sufficiently drained, the catheter body isdisplaced from the urethra back inside the body cavity under theinfluence of for instance a resilience, or is driven back therein by theuser, whereby the lumen will be closed again by the sphincter urethra.

The invention thus provides a completely new approach to(self-)catheterization, wherein the catheter body lies enclosed, and isworn wholly internally, within the body cavity in a rest position. Thecatheter body is, at least in rest position, always situated here whollywithin a sterile environment and only for evacuation of the body cavityis it manipulated transluminally in a proximal direction distally fromthe body cavity. Because the catheter body according to the invention,other than a conventional indwelling catheter, does not normally have along dwell time in the urethra, the known urethral irritations or damageare moreover avoided.

For the purpose of an autonomous self-returning character a particularembodiment of the urinary catheter according to the invention has thefeature that the anchoring body is resilient and widens gradually indistal direction on at least a side thereof directed toward the shaftpart. When carried transluminally past the closure point, the wideningpart of the anchoring body will be pressed in counter to this resilienceand thereby generate a returning force.

In a preferred embodiment the catheter according to the invention hasthe feature that the anchoring body has a relatively compact first statewhich allows a transluminal introduction and is able and adapted to takeon an at least transversely expanded, at least substantiallyballoon-shaped second state in order to prevent escape from the bodycavity.

The catheter body can here be brought beforehand into the compact firststate in order to enhance transluminal introduction while, once in thebody cavity, the second state prevents an unintended transluminal escapeof the catheter body.

A further preferred embodiment of the urinary catheter according to theinvention is characterized here in that the anchoring body isself-expandable from the relatively compact first state to the expandedsecond state. Due to this self-expandable resilient character theanchoring body requires no further means for the purpose of moving fromthe relatively compact first state to the expanded second state. Theshaft part can hereby retain a relatively slender profile, whichenhances transluminal introduction and evacuation of the catheter body.The resilient character of the anchoring body has the additionaladvantage that an unavoidable compression thereof when the catheter bodyis driven past the closure point brings about an outward drivingcounterforce toward the body cavity. When the operating member isreleased, the catheter body will thereby automatically return to it restposition, wholly within the body cavity.

A further preferred embodiment of the catheter according to theinvention has the feature that the operating member engages on thecatheter body in order to enable a user to bring the anchoring body fromthe expanded second state to an at least partially compressed thirdstate, wherein the shaft part reaches beyond the closure point, whichthird state allows a transluminal removal of the catheter body. Nofurther means are thus required for repeated catheterization andcomplete transluminal removal of the catheter body from the urethraafter a period of time. The anchoring member can always be brought intothe third state by means of the operating member in order to allow suchan evacuation. The operating member here may or may not be the same asthat with which the shaft part can be manipulated in the above describedmanner.

In a further preferred embodiment the indwelling catheter according tothe invention has the feature that the anchoring body comprises at leastone bi-stable knee lever construction with a stable starting position inthe expanded second state of the anchoring body, and that the operatingmember engages on the anchoring body in order to cause the anchoringbody, once a dead centre position has been overcome, to transform fromthe expanded second state to a relatively compact stable final positionallowing a transluminal removal of the catheter body. The anchoring bodycan here take on a reversible, unstable transitional state if thecatheter body is manipulated with the shaft part toward the closurepoint and transform to the stable third state when forced beyond thedead centre position. This transition can be felt as a bend andsubsequently allows a full removal. Without such forcing the catheterbody will on the other hand always be pressed back to the body cavitywhen the operating member is released and return to the stable secondstate. A particularly user-friendly indwelling catheter is thus realizedwhich can, without further instruments, be operated as desired and, ifdesired, be completely removed by the user, for instance in order to beeventually exchanged after a determined period of wear considered to besafe.

A particular embodiment of the catheter according to the invention hasthe feature that the anchoring body comprises a number of linkedresilient filaments which are connected to a shaft part outer end andwhich are mutually separated in a peripheral direction between a top andthe shaft outer end by longitudinal incisions, which filaments are ableand adapted to transform from a straightened first state to alongitudinally curved state. These are specifically resilient filamentswhich flex from an unstable straightened state to a stable curved stateas soon as the filaments are released. In a further particularembodiment the catheter according to the invention is characterized herein that the filaments are formed integrally with the shaft part. Suchfilaments can for instance be released from a shaft part body with highprecision by means of laser cutting or a similar process. In thecompressed first state of the anchoring body the filaments liestraightened, optionally under tension, roughly in line with the shaftpart so as to allow a transluminal displacement in the urethra. Bybringing the filaments or allowing them to move to their curved statethe anchoring body takes on an expanded second state. In a rest positionof the catheter this second state will be maintained by the anchoringbody in order to prevent an unintended escape of the catheter body fromthe body cavity.

The operating member can be embodied in different ways. In a particularembodiment the catheter is characterized in this respect in that theoperating member comprises a pull member, in particular a pull cord. Thecatheter body can thus be pulled using the operating member in order tocarry the catheter body transluminally past the closure point and, ifdesired then remove it completely. The anchoring body is heresufficiently compressed or optionally even folds down to a relativelycompact third state in order to allow such a removal.

A further particular embodiment of the catheter according to theinvention has the feature that the operating member comprises a torsionmember, in particular a torsion wire. The operating member thus not onlyallows the catheter body to be pulled, but the catheter body can also berotated about a longitudinal axis thereof by twisting the operatingmember. It is thus possible to achieve that the expanded anchoring bodynestles around the shaft part so as to thus take on a relatively compactstate which allows a trouble-free transluminal removal of the catheterbody.

During use the operating member in the catheter according to theinvention is in principle the only physical connection between the urinebladder with the catheter body therein on the one hand and the exteriorof the user on the other. This drastically reduces the chance of theentry of bacteria and other micro-organisms or contaminations whencompared to classic indwelling catheters with a hollow shaft part whichprotrudes to the outside. In order to further suppress this bacterialshort cut a preferred embodiment of the urinary catheter according tothe invention has the feature that the operating member comprises amonofilament wire. Such a wire is manufactured integrally with a solidcore and is not twined, so that there are no cavities or other spacespresent in which microorganisms or contaminations can linger. Such awire can moreover take a relatively thin form so that the overall outersurface area thereof is small.

The operating member can fulfil a multiple function, i.e. serve both tocarry the catheter body past the closure point in order to drain thebody cavity and to fully remove the catheter body transluminally. Such amultiple operation simplifies the design of the catheter but requires acertain dexterity and feel in the user so that the one function is notperformed unwittingly with the same operating member while the other wasintended. In order to avoid this latter, a further embodiment of thecatheter according to the invention has the feature that a furtheroperating member engages on the shaft part of the catheter body and,just as the first operating member, extends proximally relative to aproximal outer end of the shaft part. The catheter body thus hasindividual operating members for the purpose of different manipulationswith the catheter body.

In order to prevent irritations or rejection symptoms in and around thebody cavity, a further particular embodiment of the indwelling catheteraccording to the invention has the feature that the proximal end of theshaft part narrows gradually, and in particular is rounded. A strong oreven sharp transition is thus prevented during an introduction of theshaft part from the body cavity into the lumen, which enhances comfort.In a further embodiment of the catheter according to the invention agradual transition of the transverse dimensions is also provided forsimilar reasons between the shaft part and the anchoring member. Inaddition, use is preferably made in a further embodiment of at least anexternal surface of a biocompatible plastic for at least the greaterpart of the catheter body.

The invention further relates to a device for transluminal insertion ofan indwelling catheter in a user-friendly and practical manner.According to the present invention such an insertion device comprises aninsertion sleeve with a longitudinal cavity open on at least a distalside for receiving the catheter body for axial displacement therein, anda proximal push member which lies with a distal outer end in thelongitudinal cavity against a base part of a shaft part of the catheterbody, and which protrudes with a proximal outer end outside theinsertion sleeve. Prior to the introduction thereof the catheter body isthus enclosed for axial displacement in the insertion sleeve and isbrought together therewith substantially up to the body cavity. Thecatheter body can then be forced out of the insertion sleeve using thepush body and move into the body cavity. The insertion sleeve is thenremoved together with the push member, wherein the catheter body remainsin the cavity. The introduction of the catheter is thus not onlyexceptionally user-friendly and easy to perform by the user him/herself;the insertion sleeve moreover avoids contact with the catheter body sothat this latter can be inserted clean and possibly even fully sterile.

A preferred embodiment of the insertion device has the feature here thatthe push member comprises a longitudinal body cavity open on at least adistal side for receiving an operating member of the catheter for axialdisplacement therein. The push member thus provides space for theoperating member of the catheter which becomes available when the pushmember and the insertion sleeve are removed, but which is hygienicallystowed away up to that point.

For the purpose of a particularly hygienic or even sterile insertion, afurther preferred embodiment of the insertion device according, to theinvention has the feature that the insertion sleeve is receiveddisplaceably in a longitudinal cavity of a placing sleeve and that theplacing sleeve is provided with ejection means which are able andadapted to act on the insertion sleeve in order to drive this latterdistally out of the placing sleeve. The placing sleeve is here placed onor a little into a luminal outlet and the insertion sleeve is thenpushed therefrom by means of the operating member. The insertion sleevedoes not therefore have to be touched and remains as free as possiblefrom bacterial contamination.

In order to enhance a sterile, insertion a further preferred embodimentof the insertion device according to the invention has the feature thatthe placing sleeve comprises an antiseptic means, in particular anantibiotic gel or liquid, at least inside a distal outer end thereof. Aquantity of this means can for instance be provided on a distal outerend of the placing sleeve so that the insertion sleeve passestherethrough before entering luminally. An antiseptic introduction isthus achieved and thus prevents internal infections. In order to preventthe means drying, out, and otherwise also for a hygienic closure of thewhole, a further preferred embodiment of the insertion device accordingto the invention has the feature that the placing sleeve can be closedat a distal outer end, in particular with a removable cap, film or plug.

In order to facilitate, insertion of the insertion sleeve with thecatheter body therein, a further preferred embodiment of the deviceaccording to the invention has the feature that the placing sleeve isprovided at a distal outer end with positioning means narrowing towardthe outer end. The positioning means here provide for a self-locatingcharacter of the placing sleeve so that it automatically centresdirectly in front of an exit of the urethra, and moreover ensure acertain widening of the urethral opening, which contributes further tothe comfort of insertion of the catheter body. In a particularembodiment the device according to the invention is characterized herein that the positioning means comprise at least one transverse wideningwhich extends from an outer periphery of the distal outer end of theplacing sleeve and tapers down to a centre line of the placing sleeveover at least a distal side thereof. Such a narrowing widening can beformed integrally over a full periphery of the placing sleeve, or forinstance comprise a number of discrete longitudinal fins or ribs whichare distributed uniformly over the periphery and which each narrowtoward an outer end.

Insertion comfort is further enhanced with a further particularembodiment of the device according to the invention, which ischaracterized in that at least the insertion sleeve follows a radius ofcurvature, particularly one which is adapted to a usual curvature of aurethra of a user. The insertion sleeve will thus be less likely to acton the urethral wall during introduction thereof into the urethra,thereby preventing possible damage thereto and a painful sensation. Acertain radius of curvature moreover provides ergonomic advantages whichenhance handling and operation of the device.

A particular preferred embodiment of the insertion device has thefeature that the ejection means comprise an outer casing which enclosesthe placing sleeve at a proximal outer end in axially displaceablemanner, and that the outer casing is able and adapted to act on aproximal outer end of the insertion sleeve in order to drive this latterdistally outside the placing sleeve during an axial displacement of theouter casing over the placing sleeve. The insertion sleeve is thuswholly concealed in successively the outer casing and the placingsleeve. By carrying the outer casing over the placing sleeve in distaldirection the insertion sleeve can be carried distally outside theplacing sleeve over a corresponding distance and received transluminallyin the urethra. Direct hand contact with the insertion sleeve can hereinbe avoided, whereby this procedure can be performed in completelyhygienic manner and, if desired, by the user him/herself.

In a further particular embodiment the insertion direction is hereincharacterized in that the outer casing comprises on a proximal side anend wall with a bore in which the push body is displaceable. Once theinsertion sleeve has been placed transluminally, the push member canthus be actuated from the proximal side in order to drive the catheterbody distally out of the insertion, sleeve. A more or less close fit ofthe push member in the bore here prevents the entry of micro-organismsor other form of contamination. The push member can optionally beenclosed by a hermetically sealing membrane which connects to a proximalend wall of the device to prevent any form of entry of substancesforeign to the body.

For the purpose of economic manufacture and from an ergonomic viewpoint,a further particular embodiment of the device according to the inventionhas the feature that at least substantially all components thereof aremanufactured from plastic, in particular a biocompatible plastic.

The above specified catheter and device according to the inventionprovides a wholly new approach in respect of urinary catheterization,wherein a drainage channel through the sphincter urethra is providedfrom the inside instead of from the outside. A method forself-catheterizing of a urine bladder with a catheter, wherein acatheter body is introduced transurethrally at least partially into theurine bladder, is characterized for this purpose according to theinvention in that the catheter body is carried fully into the urinebladder distally past a urethral closure point of the sphincter urethra,that from the urine bladder the catheter body is manipulated with aproximal side thereof beyond the urethral closure point in order toevacuate liquid from the urine bladder via the at least one liquidchannel of the catheter body, and that following said evacuation thecatheter body is once again admitted fully into the urine bladderdistally beyond the closure point. An exceptionally practicalself-catheterization is thus possible which can be performed incompletely sterile manner, i.e. from the inside, and partly for thisreason considerably limits the chance of complications. The catheterbody is here substantially always situated outside the urethra, so thatirritation or damage to a wall thereof is prevented as far as possible.

A preferred embodiment of the method according to the invention has thefeature here that the catheter body is carried proximally beyond theclosure point counter to a resilience of an anchoring body thereof, andthat the catheter body is released, once the urine bladder has beensufficiently evacuated, in order to have the catheter body once againtake up a starting position located wholly within the urine bladderdistally beyond the closure point.

The invention will now be further elucidated on the basis of anexemplary embodiment and an accompanying drawing. In the drawing:

FIG. 1 shows an exemplary embodiment of an insertion device with aurinary catheter according to an exemplary embodiment of the inventionas individual components;

FIG. 2 shows a longitudinal section of the device with the catheter ofFIG. 1 in assembled state;

FIGS. 3A-3D show successive states of the insertion device and catheterof FIG. 1;

FIGS. 4A-4E show different stages of the use of the catheter of FIG. 1;

FIGS. 5A-5C show wholly schematic views of a first embodiment of amethod for placing and operating a catheter according to the invention;and

FIGS. 6A-6C show wholly schematic views of a second embodiment of amethod for placing and operating a catheter according to the invention.

The figures are otherwise purely schematic and not drawn to scale. Forthe sake of clarity some dimensions in particular may be exaggerated toa greater or lesser extent. Corresponding, parts are designated in thefigures with the same reference numeral.

The insertion device of FIG. 1 comprises an outer casing 10 which servesas a handle and which receives a placing sleeve 11 with a proximal sidein axially displaceable manner. The parts of the insertion device areall manufactured from a biocompatible plastic in order to enhanceacceptance in the body and to avoid irritations or even rejection.Placing sleeve 11 fully encloses the actual insertion sleeve 12, whichthereby remains as free as possible from contamination. At a distalouter end the whole is sealed with a sealing cap 13 or other removablesealing means, such as for instance a removable plug or sealing foil.Optionally situated immediately in front of cap 13 or between insertionsleeve 12 and placing sleeve 11 is a quantity of antiseptic gel 15 orother antibiotic agent for maintaining a sterile environment. Inaddition, the gel fulfills a lubricating function when insertion sleeve11 is inserted.

In order to achieve an accurate and user-friendly placing of placingsleeve 11 on a female urethral opening, positioning means narrowingtoward the outer end are provided at the distal outer end of the placingsleeve in the form of a transverse widening 18 which extends from anouter periphery of the distal outer end of the placing sleeve over awhole periphery thereof and tapers down to a centre line of the placingsleeve over at least a distal side thereof. Instead of such an integralmember it is also possible to opt for a number of discrete longitudinalfins which extend from an outer periphery of the distal outer end inuniformly distributed manner and narrow toward the outer end. On adistal side the widening 18 tapers down to a centre line of the placingsleeve and, when the placing sleeve is placed, thus centres the distalouter end thereof in flout of the urethral opening, which is here alsostretched slightly in order to allow a more comfortable introduction ofthe catheter to take place. Insertion sleeve 12 can thus exit distallyfrom the placing sleeve in relatively unimpeded manner and enter theurethra transluminally. The urethral wall is thus spared as much aspossible. The female urethra usually has a length of between 5 and 7centimeters. The length of the insertion sleeve is adapted hereto.

At a proximal outer end the outer casing 10 comprises an end wall 16having therein a bore 17 in which a push member 14 is close-fittinglydisplaceable, see also FIG. 2. In the assembled state, see FIG. 2, endwall 17 is connected to a proximal outer end of the insertion sleeve, sothat there is a co-action therebetween for the purpose of driving theinsertion sleeve distally out of the placing sleeve when the outercasing is displaced in a distal direction. Situated in turn in insertionsleeve 12 is the actual catheter 20-25 which, together with insertionsleeve 12 and push member 14, lies in a sterile part of the devicesurrounded by placing sleeve 11 and outer casing 10 which, together withthe sealing cap, form on their outer a non-sterile part of the device.Owing to this strict compartmentalization of the insertion device, itdoes not per se require a further, optionally sterile packaging.

A catheter body of the catheter comprises an anchoring body 20 between atip 23 of the catheter and a catheter shaft part 21. Shaft part 21,catheter tip 23 and anchoring body 20 here form as integral whole theactual catheter body. Shaft part 21 is hollow along its full length inorder to provide space for a longitudinal liquid channel which opensboth proximally and distally inside anchoring body 20. Shaft part 21thus provides a drainage channel along which liquid can drain away. Anoperating member 24 in the form of a pull cord with handle 25 isconnected to the anchoring body to enable manipulation of the catheterbody therewith once it has been inserted. Anchoring body 20 comprises anumber of resilient filaments 22 which are mutually separated in alongitudinal direction by incisions. In the assembled state thefilaments rest against an inner wall of insertion sleeve 12 counter totheir resilience. Having moved out of this position, the filamentsspring into an expanded rest position, see FIG. 3F, and thus impart morevolume to the anchoring body.

For optionally self-insertion of the catheter the sealing cap 13 isfirst removed, see FIG. 3A, and insertion device 12 is placed with thedistal outer end of placing sleeve 11 against or a little into theurethral opening. Placing means 18 herein centre the whole a littleinside the urethra. Outer casing 10 is then displaced with the handle ina distal direction roughly to the distal outer end of placing sleeve 11in order to drive insertion sleeve 12 distally over a correspondingdistance out of placing sleeve 11 and to carry it transluminally insidethe urethra, see FIGS. 3B and 4A. The various components are dimensionedhere such that a distal outer end of the insertion sleeve now liessubstantially in front of or a little beyond an exit of a body cavityfor catheterizing, in particular the urine bladder, see FIG. 4A. Theinsertion sleeve here follows a certain radius of curvature, indicatedin the figures. Which is adapted to a usual curvature of the femaleurethra so as to allow the introduction to take place as gradually aspossible. The design of the placing sleeve and casing in this exampleare also adapted to give the whole a feminine character and to enhancethe ergonomics of the whole.

When insertion sleeve 12 has been inserted substantially fully into theurethra, push member 14 is pressed in for the purpose of drivingcatheter body 20-23 distally out of insertion sleeve 12, see FIGS. 3Cand 411. Due to the resilient nature of filaments 22 the anchoring bodyis self-expanding, whereby it transposes of itself from the compactstate enclosed in the insertion sleeve to an expanded second state asshown in FIGS. 3C and 4B. In this state anchoring body 20 fixes catheterbody 20-23 in the urine bladder so that the catheter body does notescape therefrom unintentionally. The insertion device is now retracted,see FIG. 3D, wherein catheter body 20-23 and pull cord 24,25 connectedthereto remain behind in respectively the urine bladder and the urethra,see FIG. 4B. The pull cord is long enough to be reached externally.

FIG. 4B shows a rest position wherein catheter body 20-23 residesinternally relatively freely inside body cavity 50. Catheter body 20-23is here fully closed off from the outside world so that it does notallow passage for substances and micro-organisms foreign to the body. Asterile environment can thus be maintained for a long period of time. Inorder to enhance this further, use is made in this example for theoperating member of a monofilament wire 24, for instance of a plasticsuch as polyamide (Nylon®) or polytetrafluoroethylene (Teflon®). Such awire is not twined or otherwise wound, but has a completely flat andsmooth outer surface to which bacteria or other micro-organisms cannotadhere, or hardly so.

In order to evacuate liquid from body cavity 50 the catheter body ispulled in proximal direction out of cavity 50 inside urethra 52 usingthe pull cord, see FIG. 4C. The catheter body is pulled until a proximalside of shaft part 21 comes to lie beyond a closure point 53 of theurethra, see FIG. 4D. The urethra is here normally held closed by thesphincter urethra 54 with the greatest pressure. This closure is nowhowever opened by the cavity in shaft part 21, which provides anevacuation channel to urine from urine bladder 50 to urethral opening52. The urine here exits into a toilet or, if desired, the urine iscollected in a collecting member provided for this purpose.

Closure point 53 generally lies about halfway along the urethra, i.e.,at a distance of about 2-3 centimeters from the urine bladder. A lengthof catheter body 20-23 is adapted hereto to enable spanning of thisdistance and thus provide an open urinary passage, while this length ison the other hand smaller than the internal size of the urine bladder sothat in a rest position the catheter body lies received in the urinebladder in a manner which for a user is at least substantially whollyimperceptible and sterile. In this example use is thus made of acatheter body with a shaft part 21 of about 15-25 millimeters and withan overall length of about 40-60 millimeters in the expanded state andabout 70-90 millimeters in the extended state. The anchoring body herewidens gradually to a diameter of about 25-45 millimeters.

The displacement of catheter body 20-23 beyond closure point 53 takesplace counter to the resilience of anchoring body 20. When pull cord 24is released, the catheter body will thereby be pressed backautomatically and once again take up its starting position in the urinebladder as shown in FIG. 4B. The catheter is now ready for a subsequentuse.

For definitive removal of the catheter body the pull cord 24 is pulledfurther until a bi-stable knee lever construction in filaments 22 isfelt to fold down to the third state shown in FIG. 4E. Just as the reststate, this state is stable, although the profile of anchoring body20-23 is here significantly more slender, which allows a transluminalremoval when cord 24 is pulled all the way back. The catheter can now bediscarded and, if desired, replaced with a new one. The catheteraccording to the invention can thus be worn safely and comfortably overa relatively long period of time and provides a solution particularlyfor users with a bladder deficiency whereby they are insufficiently ableto develop a urine pressure autonomously which is sufficient to overcomethe closing pressure of the sphincter urethra.

The different stages of insertion and operation of the catheter areagain shown schematically in FIGS. 5A-5C. In the situation shown in FIG.5A the catheter body is inserted to a position fully in the bladdercavity. If anchoring body 20 is self-expanding, it automatically springsinto the transversely expanded state shown FIG. 5B. It is also possiblethat the anchoring body is not self-expanding but only takes on such anexpanded state after being brought manually into this state, forinstance by pulling operating member 24,25 which in this case engages ona distal tip 23 of the anchoring body beyond filaments 22. The expandedstate produces resistance which prevents the catheter body exiting thebladder and will bring about a returning force if the catheter body isnevertheless forced transluminally into the urethra by the user pullingthe operating member. With an excessive pulling force the user will pullthe anchoring body wholly past a closure point of the sphincter urethraand the anchoring body folds down into the stable final position shownin FIG. 5C of a hi-stable knee lever construction present in filaments22.

An alternative embodiment of arranging and manipulating a catheteraccording to the invention is shown schematically in FIGS. 6A-6C.Anchoring body 20,22 is here self-expanding, which means that it springsautomatically from the compressed state shown in FIG. 6A to the stateshown in FIG. 6B as soon as it is released. In the state shown in FIG.6A the catheter body is enclosed in for instance a sleeve, wrapper orotherwise held forcibly in this state using fixation means in order toallow a transluminal introduction via the urethra. Once in the bladdercavity, the fixation means are removed and anchoring, body 20,22 isreleased, whereby it springs into the state shown in FIG. 6B andprevents unintended exit of the catheter body from the bladder. Theoperating member is connected in this case to a proximal outer end ofshaft part 21. If cord 24,25 is pulled, anchoring body 20,22 will bepulled transluminally into the urethra counter to its intrinsicresilience and manipulated into the state shown in FIG. 6C. Initially,this state will impose a returning force on the catheter body untilanchoring, body 20,22 is pulled roughly up to a position beyond a middlepoint thereof into the urethra. The urethra urges and then holds theanchoring body fully in the state shown in FIG. 6C in order to allowonly a fully transluminal removal of the catheter body.

Although the invention has been further described on the basis of only asingle exemplary embodiment, it will be apparent that the invention isby no means limited thereto. On the contrary, many more variations andembodiments are possible within the scope of the invention for theperson with ordinary skill in the art. Instead of an optionallyautomatically fully expanding body it is thus also possible to apply ananchoring body which in a first state lies relatively flat in line withthe shaft part and which is transversely or radially expanded in asecond state, strictly speaking without thereby having increased insize.

The invention claimed is:
 1. Method for self-catheterizing of a urinebladder with a catheter, wherein the catheter comprises a catheter bodyand at least one operating member extending proximally of said catheterbody and being connected durably thereto, said catheter body comprisingan elongated shaft portion having a longitudinal liquid channel forguiding a liquid flow between a distal side and a proximal side thereof,and said catheter body comprising an anchoring portion distally of saidshaft portion, said anchoring portion comprising an anchoring body whichis deployable from i) a relatively slender first state, which allows atransluminal introduction of said catheter body in a user's body cavitydefined by a female bladder, into ii) an expanded second state, whichprevents an inadvertent escape of the catheter body from said bodycavity defined by said bladder, said shaft portion having a sufficientlength to reach beyond a closure point of a luminal sphincter while theanchoring body resides in said user's body cavity defined by saidbladder, and said catheter body being sufficiently compact to bereceived completely inside said user's body cavity defined by saidbladder, wherein the anchoring body is self expandable from saidrelatively slender first state into said expanded second state, whereinsaid anchoring body is balloon shaped in said expanded state and widensgradually in a distal direction at a side which is directed towards saidshaft portion, wherein said anchoring body comprises a number ofresilient filaments which are connected to said shaft portion and whichare mutually separated in a peripheral direction by longitudinalincisions, which filaments are configured to transform from astraightened state to a longitudinally curved state and which filamentsare configured and sufficiently resilient to expel said catheter bodyfrom said urethral sphincter and into said bladder in the absence of aforce applied on said operating member, said method comprising:introducing the catheter body transurethrally at least partially intothe urine bladder, with the catheter body being carried fully into theurine bladder distally past a urethral closure point of the sphincterurethrae, manipulating the catheter body from the urine bladder with aproximal side thereof beyond the urethral closure point in order toevacuate liquid from the urine bladder via the longitudinal liquidchannel of the catheter body, and following said evacuation, once againfully admitting the catheter body into the urine bladder distally beyondthe closure point.
 2. Method as claimed in claim 1, wherein, theanchoring body of the catheter body is brought in the urine bladder froma relatively slender state into a transversely expanded state, thecatheter body is carried proximally beyond the closure point counter toa resilience of the anchoring body in order to allow liquid to escapefrom the urine bladder, and the catheter body is released after theurine bladder has been sufficiently evacuated in order to have thecatheter body once again take up a starting position located fullywithin the urine bladder distally beyond the closure point.
 3. Method asclaimed in claim 2, comprising the further step of removing the catheterbody transurethrally wholly out of the urine bladder and urethra. 4.Method as claimed in claim 1, comprising the further step of removingthe catheter body transurethrally wholly out of the urine bladder andurethra.